Expedited and Full Board Protocol Summary Form

advertisement
Human Research
Protocol #:
ORSP #:
Sponsor Tracking #:
Institutional Review Board
Protocol Summary Form
Directions: Complete the form. Contact [email protected] with any questions or if you would like feedback on a
draft of your protocol prior to IRB review.
Type of Review being sought: Exempt
Expedited
Full Review
Principal Investigator (PI):
Department:
Phone:
E-mail:
Project Title:
PI Certification
By submitting this document, I agree to accept primary responsibility for the conduct of this project as approved by the IRB. The
project cannot begin until I receive documentation of IRB final approval.
Principal Investigator Name
Date
FOR STUDENTS, a Marquette faculty member must supervise your project. By agreeing to serve as faculty supervisor for this
project the Marquette faculty member listed below agrees to review the research plan before submission and provide ongoing
supervision and guidance for the project to ensure compliance with human subject research guidelines.
Faculty Supervisor Name
Faculty Supervisor Department
Submission Instructions: Email this completed form and any supporting documents including consent
forms, information sheets, surveys, interview questions, etc. as attachments to [email protected] with the
following subject line:
New Study Submission for [first and last name of PI]
 In the body of e-mail, include the title of the study and an itemized list of attachments.
 The email address of the sender must be the Principal Investigator’s Marquette email.
 If the PI is a student, the faculty advisor must be cc’d.
Once submitted, the IRB will e-mail back a response of receipt. If you do not receive an e-mail
confirmation of submission within 3-5 days of submission, please contact the IRB by phone (288-7570) or
email ([email protected]) to verify receipt.
1
Marquette University, IRB Protocol Summary Form
Revised 09/13/2013
***Please note that in order to choose any of the check boxes on this form,
you must double click the box and select "Checked" as the Default
Value***
Section A: RESEARCH PROJECT CHARACTERISTICS
1. This is a:
Research Proposal
Thesis/Dissertation
Class Project (list Dept. & Course #):
Other (specify):
2. Grant or Contract Funded:
Yes
Funding is Pending
No
Sponsor/Source of funding:
If external funding, have you registered your project with Research and Sponsored Programs (ORSP)?
Yes
No
If Yes, Please list your ORSP Reference #:_________________
If your project is grant funded, submit a copy of the funding/grant proposal and list the
AGENCY GRANT NUMBER:__________________________
If the project title listed on page 1 of this application is different from your grant title, list the
grant title:_____________________
If the funding agency requires an official IRB approval letter or form, list the program area, contact
person, title and complete mailing address:
3. Does the investigator or key personnel have a potential financial conflict of interest in this study
that should be disclosed?
Yes
No If Yes, Please explain:
4. PI Status:
Undergraduate
Graduate
Faculty/Administrator
Other (specify):
5. Provide the names, titles and affiliations of all investigators (include yourself, co-PIs, other
investigators, and students). Please use an attachment if more space is required.
OHRP interprets an “investigator” to be any individual who is involved in conducting human subjects
research studies. Such involvement includes:
 obtaining information about living individuals by intervening or interacting with them for research
purposes;
 obtaining identifiable private information about living individuals for research purposes;
 obtaining the voluntary informed consent of individuals to be subjects in research; and
Marquette University’s Office of Research Compliance - 560 N. 16th Street, Room 102
Phone: 414-288-7570, Fax: 414-288-6281, Web: www.mu.edu/orc, Email: [email protected]
2

Marquette University, IRB Protocol Summary Form
Revised 09/13/2013
studying, interpreting, or analyzing identifiable private information or data for research purposes.
Note that any collaborative work with another institution will require the submission of that
institution's IRB approval letter.
Name
Institution
Status
Project Role
(Faculty, Grad.,
Undergrad., etc.)
(Co-PI, Key or NonKey Personnel,
Consultant, etc.)
Contact e-mail
Tutorial*
(Attached or
On File w/
MU ORC)
*Please note that Training Certificates are required for all human subject investigators.
Certificates can be obtained by visiting http://phrp.nihtraining.com/users/login.php and
completing the IRB Tutorial Designed by the National Institute of Health. Copies of Training
Certificates are to be forwarded to the Office of Research Compliance.
6.
Do you wish to have this project considered for Exempted Review?
Yes
No (See Submission Requirements on ORC web site for definition and list of
categories)
If Yes, identify the Exemption category number you believe covers your project:
Category 1
Category 2
Category 3
Category 4
Category 6
Category 5
Explain your basis for this level of review here:
7. Do you wish to have this project considered for Expedited Review?
Yes
No (See Submission Requirements on ORC web site for definition and list of
categories)
If Yes, identify the Expedited Review category number you believe covers your project:
Category 1
Category 2
Category 3
Category 4
Category 5
Category 6
Category 7
Explain your basis for this level of review here:
8. Inclusive dates of Project: (Project may not start prior to approval)
From: IRB Approval Date
To:
9. How long is the active involvement of participants in the study? (e.g. six half-hour sessions over
six months):
10. Research Location: Where will the research be performed (if not on campus, please provide the full
address; if online, please indicate online)?
Marquette University’s Office of Research Compliance - 560 N. 16th Street, Room 102
Phone: 414-288-7570, Fax: 414-288-6281, Web: www.mu.edu/orc, Email: [email protected]
3
Marquette University, IRB Protocol Summary Form
Revised 09/13/2013
Note: If the research will be conducted in a school or institution other than Marquette
University, include a letter, on letterhead stationery, of permission from that institution and/or
its IRB. This letter must be received by the ORC prior to IRB approval.
11. What do you intend to do with the data collected?
Publish paper
Other (please describe):
Present at conferences/meetings
Section B: SUBJECT RECRUITMENT
12. Indicate which of the following specially protected groups will be specifically targeted as research
participants in this study (Check all that apply):
Pregnant Women/Fetuses
None of These
Children (minors under 18)
Prisoners
13. Indicate which of the following potentially vulnerable populations will be specifically targeted as
research participants in this study (Check all that apply):
College Students*
Physically Disabled
Institutional Residents
Terminally Ill
Cognitively Impaired
None of These
*If using Marquette students, please consult HRP Policy 98.102 Participation of Students and Employees
in Research (http://www.marquette.edu/researchcompliance/human/documents/HRPolicy98.102StudentsEmployees.pdf)
14. Will both genders have an equal opportunity to participate as subjects in this research project?
Yes
No If No, explain your answer:
15. Will subjects of different racial and ethnic consideration have an equal opportunity to participate in
this research project?
Yes
No If No, explain your answer:
16. How many subjects will be recruited into your research project as justified by the hypothesis and
study procedures?
a) Total number of subjects required to complete your study: _____
How was this number determined? If a power analysis or other method was used, please include
this in your response:
b) Total number of subjects to be recruited (to account for drop out, etc.): _____
c) Explain the reason for difference between (a) and (b) above (e.g. past studies have shown that there
is a 50% drop out rate for students, the study is longitudinal and a drop out rate of 30% is
anticipated):
Marquette University’s Office of Research Compliance - 560 N. 16th Street, Room 102
Phone: 414-288-7570, Fax: 414-288-6281, Web: www.mu.edu/orc, Email: [email protected]
4
Marquette University, IRB Protocol Summary Form
Revised 09/13/2013
Please Note: If at a later time it becomes apparent that you need to increase your sample size, you will
need to submit an IRB Protocol Amendment Form, including your justification for additional subjects.
17. What is the age range of subjects (please provide a specific range)?
18. What is the source of the subject list?
19. Who will contact the subjects (name and affiliation)?
20. How will subjects be contacted? (Check all that apply)
Advertisements*
Letters*
Telephone Lists
Student Pool
Direct person-to-person solicitation
Other (please specify):
Notices*
Random Telephone Dialing
E-mail*
University News Briefs*
* A copy must be submitted for IRB approval. For letters, notices, advertisements, and others, submit verbatim
copies.
21. Data collection methods: (Check all that apply and provide copies of all tools)
Questionnaire or Survey1
Archival Data2
Instruction/Curriculum
Testing/Evaluation
Observation4
Intervention
Focus Groups
Other (please describe):
Interview
Video Recording3
Audio Recording3
1
If conducting an online survey, consult the University’s Online Survey Policy
(http://www.mu.edu/upp/documents/upp1-22.pdf)
2 If using archival data, describe in the Narrative section (question 48) whether data are de-identified.
3 If you select video and/or audio recording, please provide further explanation in the Narrative section
(question 48) regarding confidentiality of the recording(s).
4 If you select observation, please provide further explanation in the Narrative section (question 48)
regarding who you plan to observe, where you plan to observe (public or private location), and the type
of data you will be collecting.
NOTE: If data collection tools are provided in a language other than English, provide both the English
and non-English versions.
22. If deception or experimental manipulation is used, please explain why it is necessary (as opposed
to convenient) for this study. Include plans for how and when subjects will be debriefed and attach
a copy of your debriefing sheet, if applicable:
23. Does any part of this activity have the potential for coercion of the subject (for example, a student
being recruited by a teacher who controls his or her grade may feel coerced)?
Yes
No
24. If Yes, explain and describe the proposed safeguards:
Note: If you are planning to recruit Marquette employees or students, consult the HRP Policy
regarding Participation of Students and Employees in Research
Marquette University’s Office of Research Compliance - 560 N. 16th Street, Room 102
Phone: 414-288-7570, Fax: 414-288-6281, Web: www.mu.edu/orc, Email: [email protected]
5
Marquette University, IRB Protocol Summary Form
Revised 09/13/2013
(http://www.marquette.edu/researchcompliance/human/documents/HRPolicy98.102StudentsEmployees.pdf)
Section C: CONSENT OF RESEARCH SUBJECT
25. What type of consent will be used? You must attach a clean copy that will receive the IRB
approval stamp. Consult the ORC website for the consent form instructions and required
template.
Written Consent
Waiver
Oral Consent
Information Sheet
Guardian Permission & Adult Assent
Online Consent
Parent Permission & Child Assent
Other (please describe):
26. If you are requesting a waiver of informed consent, address each of the following:
a) The research involves no more than minimal risk to the subjects;
b) The waiver will not adversely affect the rights and welfare of the subjects;
c) The research could not practicably be carried out without the waiver; and
d) Whenever appropriate, subjects will be provided with additional pertinent information after
participation.
Considering the above requirements for a waiver of informed consent, please describe how your
research qualifies for this waiver:
27. Do you intend to use an informed consent document in a language other than English?
Yes
No If Yes, provide both the English and non-English versions.
28. If you are using an oral consent, describe the rationale, how it will be documented, and include a
copy of the oral presentation; it must include all information required of written informed consents:
Section D: CONFIDENTIALITY
29. Where specifically will consent forms be kept (building location, room #, please include full
address if off campus) AND who will have access?
30. How will research subjects be identified in the research data (by name, code, number, etc.)?
31. At any time during your research will a direct link exist between collected data and research
subjects? (i.e. participants' data can be directly linked to their name). For example, data collection
sheet has a location for participant’s name to be recorded.
Yes
No
At any time during your research will an indirect link exist between collected data and research
subjects? (i.e. participants' data can be indirectly linked to their name.) For example, data collection
sheet has a location for subject number to be recorded. In addition, a spreadsheet exists that links that
subject number to a participant’s name. Many multi-session and longitudinal studies use indirect links.
Yes
No
Marquette University’s Office of Research Compliance - 560 N. 16th Street, Room 102
Phone: 414-288-7570, Fax: 414-288-6281, Web: www.mu.edu/orc, Email: [email protected]
6
Marquette University, IRB Protocol Summary Form
Revised 09/13/2013
If either of the two above questions are answered “yes,” please describe the provisions for security of
any links:
32. When data results are reported/disseminated:
Will identifiers be used (for example: participant’s name will be published in article)?
Yes
No
Will it be presented in aggregate form (For example: Group characteristics only=Yes, Individual
Quotations=No)?
Yes
No
33. Will research data (raw data) be available to anyone other than the IRB, sponsor and study
personnel?
Yes
No
If Yes, who will this data be shared with, describe how the data will be safeguarded, and be sure to
include this information in the consent form (if applicable):
34. Describe how research records, data, electronic data, (including deidentified data) etc. will be
stored (i.e. locked file cabinet, password protected computer file, etc.) AND for how long (research
records must be maintained a minimum of 3 years; if kept indefinitely, please state this and
indicate it on the consent form):
35. Describe how the research records, data, electronic data, (including deidentified data) etc. will be
destroyed (i.e. shred paper documents, delete electronic files, etc.), AND address whether they may
be used for future research purposes (If records will be used in the future, please indicate this on
the consent form):
36. Could any part of this activity result in the potential identification of child/adult/older adult abuse?
Yes
No
If Yes, is the mandatory report of child/adult abuse outlined in your consent?
Yes
No
37. Could any part of this activity result in the potential identification of communicable diseases or
criminal activities?
Yes
No
Section E: BENEFITS AND RISKS TO RESEARCH SUBJECTS
38. Are the direct and indirect benefits to the research subjects for involvement in this project
described in their informed consent form?
Yes
No
39. Describe the possible direct benefits to the subjects. If there are no direct benefits, please state this.
Also, describe the possible benefits to society:
Marquette University’s Office of Research Compliance - 560 N. 16th Street, Room 102
Phone: 414-288-7570, Fax: 414-288-6281, Web: www.mu.edu/orc, Email: [email protected]
7
Marquette University, IRB Protocol Summary Form
Revised 09/13/2013
40. Will any electrical or mechanical systems that require direct human contact be used (does not
include use of computers for data keeping and surveys)?
Yes
No
If Yes, attach a copy of the manufacturer's electrical/mechanical safety specification information for each
instrument/device. If the device is custom made, attach detailed description/information on design and
safety with respect to human subjects application.
***Also include the most recent safety inspection information documented on either the Marquette
University Electrical Safety Testing Documentation form or an equivalent electrical safety testing
documentation form.
NOTE: Electrical and mechanical safety inspections must be performed and documented on an annual
basis. Documentation of the most recent safety inspection must be submitted with the initial protocol, as
well as with any subsequent 3-year renewals.
41. Are the nature and degree of potential risks to research subjects described in the consent? Risks
can be physical, psychological, economic, social, legal, etc.
Yes
No
42. Describe the risks to participants and the precautions that will be taken to minimize those risks
(these risks should also appear on the consent form). If no risks identified, explain why:
Section F: COMPENSATION FOR RESEARCH SUBJECTS
43. Will research subjects be compensated or rewarded?
Yes*
No
If Yes, describe the amount of compensation, how and when it will be disbursed, and in what form:
* If subjects are recruited from MU classes, indicate whether students are receiving course credit (regular
or extra credit) and, if so, what alternatives are offered to those students who do not wish to participate
in the research.
Section G: NARRATIVE DESCRIPTION
For the following questions, try to use non-technical language that provides a first time reader (from
any discipline) with a clear understanding of the research, and avoid abbreviations. Do not "paste"
text from the grant proposal, and do not refer to the grant proposal page numbers or include
literature citations. Information given should provide the first-time reader with a clear understanding
of the proposed research. Focus your answers on the involvement and treatment of human subjects.
PROPOSED RESEARCH RATIONALE
44. Describe why you are conducting the study and identify the research question(s) being asked:
SUBJECTS TO BE INCLUDED
45. Describe any inclusion and/or exclusion criteria:
RECRUITMENT AND OBTAINING INFORMED CONSENT
Marquette University’s Office of Research Compliance - 560 N. 16th Street, Room 102
Phone: 414-288-7570, Fax: 414-288-6281, Web: www.mu.edu/orc, Email: [email protected]
8
Marquette University, IRB Protocol Summary Form
Revised 09/13/2013
46. Describe your recruitment process in a step-by-step manner:
47. Describe your informed consent process in a step-by-step manner:
SPECIFIC PROCEDURES TO BE FOLLOWED
48. Describe the methodology to be used and describe in a step-by-step manner the involvement and
treatment of human participants in the research, through to the very end of participation. Identify
all data to be collected:
Marquette University’s Office of Research Compliance - 560 N. 16th Street, Room 102
Phone: 414-288-7570, Fax: 414-288-6281, Web: www.mu.edu/orc, Email: [email protected]
9
Download